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DESCRIPTIONSuboxone (buprenorophine/naloxone)/Subutex (buprenorophine) are Schedule III narcotics. Under the Drug Abuse Treatment Act (DATA) of 2000, they can be used to treat opioid addiction outside of Opioid Treatment Programs. Only providers with qualifying credentials as defined in DATA 2000 can prescribe or dispense Suboxone or Subutex for opioid addiction therapy. Qualified providers must submit a Notification of Intent, or a "waiver notification," to the Center for Substance Abuse Treatment (CSAT, a component of SAMHSA) prior to starting therapy. Providers approved by CSAT are issued a DATA 2000 Waiver Identification number, or a "X" number, by the DEA (Drug Enforcement Agency). Both the Waiver ID number and the prescriber's regular DEA number are required on Suboxone and Subutex prescriptions for opioid addiction therapy. Besides verifying that both DEA numbers are on the prescription, there are no additional requirements for pharmacists or pharmacies to dispense Suboxone or Subutex beyond those for other Schedule III medications.
Suboxone/ Subutex are subject to diversion and abuse. Suboxone contains naloxone to deter abuse by injection. Naloxone has no effect when used sublingually due to poor absorption. However, given intravenously, naloxone blocks opioid effect and precipitates immediate withdrawal. Subutex may be used for induction in some patients during the first 2-3 days. Subutex should be administrated with supervision. Suboxone is the preferred agent for maintenance therapy, especially when clinical use includes unsupervised administration. Maintenance therapy with Subutex should be limited to those patients who cannot tolerate Suboxone or who are pregnant or breastfeeding.
POLICYEffective 8/1/12, prior authorization is required for Suboxone/Subutex when purchased at a pharmacy.
Initial treatment is approved for 6 months if the clinical criteria are met and the provider is authorized by SAMHSA to prescribe Suboxone/Subutex. A maximum of 24 months of therapy can be obtained per member lifetime. A quantity limit of 2 (two) tablets a day will be approved for Suboxone/Subutex.
Suboxone New Starts (Effective 8/1/12, a prior authorization is required for all new members taking Suboxone)
Subutex New Starts (Effective 8/1/12, a prior authorization is required for all new members taking Subutex)
Continuation of Therapy
Effective 10/1/2012, a prior authorization will be required for members currently taking (defined as members on therapy as of 8/1/2012) Suboxone/Subutex if the member does not have an opioid dependence diagnosis and/or is being treated by a non-authorized provider. A 6-month continuation request may be approved based on an approved treatment plan and taper strategy for a maximum of 24 months per member lifetime. Existing members taking Suboxone/Subutex that have already received 24 months of therapy will only be given a 6-month continuation period in order to be tapered off therapy.
Suboxone/Subutex is considered investigational when used for all other conditions, including but not limited to:
POLICY EXCEPTIONSPrior authorization for Suboxone/Subutex is not required for Federal Employee Program (FEP) and State Health Plan members.
POLICY GUIDELINESAppendix 1
Verification of DATA 200 waiver to prescribe Suboxone/Subutex for the treatment of opioid addiction.
Verification of no concurrent opioid utilization.
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Nervous/Mental Conditions, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of Medically Necessary, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY07/09/2012: New policy added.
03/27/2014: Policy reviewed; no changes.
08/31/2015: Medical policy revised to add ICD-10 codes.
02/02/2016: Approved by Pharmacy & Therapeutics (P&T) Committee. Policy guidelines updated to add medically necessary and investigative definitions.
SOURCE(S)Suboxone/Subutex Prescribing Information
Substance Abuse and Mental Health Services Administration (SAMHSA). Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addication.
American Pain Society. National Clinical Guideline. Use of Chronic Opioid Therapy in Chronic Non-Cancer Pain: Evidence Review.
SAMHSA. Buprenorphine Physician and Treatment Locator. http://www.buprenorphine.samhsa.gov/bwns_locator/index.html
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.